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Paperless Validation SoftwareAn overview of ValGenesis Paperless Validation Software Solutions Cleaning ValidationIntegrated, seamless lifecycle process across multiple groups and sites Commissioning Qualification ValidationRisk-based commissioning and qualification process Computer System ValidationError-free, paperless, fully automated lifecycle management process Analytical Method ValidationError-free, paperless, integrated analytical method lifecycle validation Cold Chain ValidationIoT capable validation for temperature controlled supply chains Equipment and Instruments ValidationQuick access to data and validated state of equipment Process ValidationSeamless connectivity across process, data, and knowledge management Electronic Logbook ManagementVerification and review (with e-signature) of equipment logs at point-of-need ComplianceSolutions designed to facilitate compliance with all industry standards and regulations VConnectData captured from equipment is plugged into all documentation and evidence
Pharmaceutical and BiotechnologyAchieve standardization and data integrity via seamless processes Medical Devices and DiagnosticsSeamlessly manage DHFs across all units and sites GxP LaboratoriesEnsure data integrity and get organized with automated audit trails Blood and TissueConsistently meet Blood Establishment Computer Software (BECS) Requirements Regulated Software CompaniesQuickly release new versions/ service packs with our test automation engines Contract Research OrganizationsEnforce approved validation plans to be audit-ready without preparation NutraceuticalsSingle environment requirements management, simplifying proof of compliance
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Example-of-Electronic-Execution---Automation,-Deviation-Management,-Esigns
Replace paper and manual processes with electronic test case execution.

Gain the Benefits of Digital Transformation with Truly Paperless Validation

  • Eliminate paper from your validation processes: no more printing, shredding, binding, storing and shipping
  • Securely archive records in controlled digital repositories for effortless findability for a record's lifetime
  • Activate "follow-the-sun validation" and real-time collaboration with remote and distributed teams

Minimize Risk and Enforce Consistency

  • Adhere to ALCOA principles and stay secure with role-based access
  • Enforce consistency with templates and maintain a risk-based approach to validation to improve compliance posture
  • Stay audit-ready with complete and organized electronic records
  • Maintain a consistent state of inspection readiness with click-to answers

FDA_21CFRPart11_Compliant     EU_Annex11_Compliant
Audit-Trail---Inspection-Readiness-and-Transparency
ValGenesis provides a rich audit trail to trace the lifecycle of any validation record.
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Real-time dashboards provide detail into the complete validation lifecycle.

Run Lean and in Real-time with Validation that Never Sleeps

  • Automate document flow and set task delegation to remove gaps and delays in validation processes
  • Complete tasks immediately with links to an individual or group
  • Eliminate interdepartmental friction with controlled templates and workflow standardization
  • Instantly route deviations for review accompanied by automated trace matrix generation
  • Execute compliant electronic signatures for reviews and approvals
  • Drill down into granular details from dynamic dashboard graphs

Scale ValGenesis VLMS with Multi-site Support

Multi-Site Diagram

Global standard enforcement with site-specific autonomy

Global and site-specific templates and workflows

Modern Technology Drives Our Validation Lifecycle Management System

Cloud Application

The fully compliant ValGenesis VLMS is a cloud application for maximum IT flexibility in deployment, integration and more. Learn more.

Language Support

ValGenesis VLMS supports six languages: English, French, German, Spanish, Chinese and Japanese to ensure processes and controls never stop from language barriers. See more technology features.

Decision-tree Logic

For ultimate efficiency gains, users complete structured forms-based assessments that automatically generate protocols based on their input. See more user features.

Integrations and APIs

ValGenesis VLMS can integrate with your other systems of records such as ERP and QMS through its comprehensive API stack.

Five Essential Capabilities of a Validation Lifecycle Management System

Why-choose-ValGenesis

Digitizing your validation processes is more than just eradicating paper. A true digital transformation process will leverage the power of data, enforce best practices and standards, and enable data integrity governance in the corporate validation process.

Here are five essential capabilities of a digital validation management solution:

  1. Enforce approved corporate validation master plans, validation policies and procedures in the corporate validation process
  2. Ensure data integrity throughout the entire validation lifecycle, from design to continuous monitoring
  3. Support global languages at the site and user level, in order to convey work instructions and operating procedures without language as a barrier
  4. Maximize transparency in drug manufacturing, storage, and logistics, with sensors communicating through IoT in real-time
  5. Leverage the power of automated software testing tools that automate validation execution to drive efficiency gains up to 80% with computer systems validation alone

ValGenesis Validation Lifecycle Management System Modules

ValGenesis VLMS is a fully capable system built on a set of integrated modules.

Validation Plan and FrameworkMaintain a consistent approach across all validation processes and sites
Content Lifecycle ManagementTrack documentation from design to change management and validation
Risk-Based ValidationEvaluate and control risk at functional and/or system levels
Electronic Test Case ExecutionExecute test cases quickly and securely, anywhere at any time
GxP Asset ManagementManage the lifecycle of GxP assets with a documented audit trail
Validation ProjectsManage complex validation projects with required quality gate checks
Periodic Review ManagementIdentify and manage the review schedules of validated GxP systems
Robotic Test Case ExecutionReduce execution time by up to 90% by removing human errors
Change Control and ManagementTrack and efficiently manage any type of change request
Dynamic Trace MatrixIdentify and fix defects related to important requirements
Requirements ManagementManage change requirements as a closed loop validation process
Retirement and Decommissioning ProcessPlan and execute the entire process with required quality gate checks
Equipment Log ManagementRecord, verify, and review logs as per approved SOPs/standards

Reach out to schedule a free, personal demo of the ValGenesis VLMS. We’ll show you our product in-depth and share our experience to identify the perfect solution for your organization.

Schedule a Demo